Comparing Mycophenolate Mofetil Regimens for de Novo Renal Transplant Recipients : The Fixed-Dose Concentration-Controlled Trial
Identifieur interne : 008E22 ( Main/Exploration ); précédent : 008E21; suivant : 008E23Comparing Mycophenolate Mofetil Regimens for de Novo Renal Transplant Recipients : The Fixed-Dose Concentration-Controlled Trial
Auteurs : Teun Van Gelder [Pays-Bas] ; Helio Tedesco Silva [Brésil] ; Johan W. De Fijter [Pays-Bas] ; Klemens Budde [Allemagne] ; Dirk Kuypers [Belgique] ; Gunnar Tyden [Suède] ; Aleksander Lohmus [Estonie] ; Claudia Sommerer [Allemagne] ; Anders Hartmann [Norvège] ; Yann Le Meur [France] ; Michael Oellerich [Allemagne] ; David W. Holt [Royaume-Uni] ; Burkhard Tönshoff [Allemagne] ; Paul Keown [Canada] ; Scott Campbell [Australie] ; Richard D. Mamelok [États-Unis]Source :
- Transplantation [ 0041-1337 ] ; 2008.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Antibiotique.
English descriptors
- KwdEn :
Abstract
Background. Fixed-dose mycophenolate mofetil (MMF) reduces the incidence of acute rejection after solid organ transplantation. The Fixed-Dose Concentration Controlled trial assessed the feasibility and potential benefit of therapeutic drug monitoring in patients receiving MMF after de novo renal transplant. Methods. Patients were randomized to a concentration-controlled (n=452; target exposure 45 mg hr/L) or a fixed-dose (n=449) MMF-containing regimen. The primary endpoint was treatment failure (a composite ofbiopsy-proven acute rejection [BPAR], graft loss, death, or MMF discontinuation) by 12 months posttransplantation. Results. Mycophenolic acid (MPA) exposures for both groups were similar at most time points and were below 30 mg hr/L in 37.3% of patients at day 3. There was no difference in the incidence of treatment failure (25.6% vs. 25.7%, P=0.81) or BPAR (14.9% vs. 15.5%, P>0.05) between the concentration-controlled and the fixed-dose groups, respectively. We did find a significant relationship between MPA-area under the concentration-time curve on day 3 and the incidence of BPAR in the first month (P=0.009) or in the first year posttransplantation (P=0.006). For later time points (day 10, month 1) there was no significant relationship between area under the concentration-time curve and BPAR (0.2572 and 0.5588, respectively). Conclusions. There was no difference in the incidence of treatment failure between the concentration-controlled and the fixed-dose groups. The applied protocol of MMF dose adjustments based on target MPA exposure was not successful, partly because physicians seemed reluctant to implement substantial dose changes. Current initial MMF doses underexpose more than 35% of patients early after transplantation, increasing the risk for BPAR.
Affiliations:
- Allemagne, Australie, Belgique, Brésil, Canada, Estonie, France, Norvège, Pays-Bas, Royaume-Uni, Suède, États-Unis
- Angleterre, Bade-Wurtemberg, Basse-Saxe, Berlin, District de Karlsruhe, Grand Londres, Hollande-Méridionale, Limousin, Nouvelle-Aquitaine, Svealand, État de São Paulo
- Berlin, Göttingen, Heidelberg, Limoges, Londres, Rotterdam, Stockholm, São Paulo
- Université de Göttingen, Université de Londres
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Comparing Mycophenolate Mofetil Regimens for de Novo Renal Transplant Recipients : The Fixed-Dose Concentration-Controlled Trial</title><author><name sortKey="Van Gelder, Teun" sort="Van Gelder, Teun" uniqKey="Van Gelder T" first="Teun" last="Van Gelder">Teun Van Gelder</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Departments of Hospital Pharmacy and Internal Medicine, Erasmus Medical Center</s1><s2>Rotterdam</s2><s3>NLD</s3><sZ>1 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Tedesco Silva, Helio" sort="Tedesco Silva, Helio" uniqKey="Tedesco Silva H" first="Helio" last="Tedesco Silva">Helio Tedesco Silva</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Nephrology, Hospital do Rim e Hipertensao</s1><s2>São Paulo</s2><s3>BRA</s3><sZ>2 aut.</sZ></inist:fA14><country>Brésil</country><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="De Fijter, Johan W" sort="De Fijter, Johan W" uniqKey="De Fijter J" first="Johan W." last="De Fijter">Johan W. De Fijter</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Nephrology, Leiden University Medical Center</s1><s3>NLD</s3><sZ>3 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Department of Nephrology, Leiden University Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Budde, Klemens" sort="Budde, Klemens" uniqKey="Budde K" first="Klemens" last="Budde">Klemens Budde</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Nephrology, Charité University</s1><s2>Berlin</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Kuypers, Dirk" sort="Kuypers, Dirk" uniqKey="Kuypers D" first="Dirk" last="Kuypers">Dirk Kuypers</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Nephrology and Renal Transplantation, Leuven University</s1><s3>BEL</s3><sZ>5 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Department of Nephrology and Renal Transplantation, Leuven University</wicri:noRegion></affiliation></author><author><name sortKey="Tyden, Gunnar" sort="Tyden, Gunnar" uniqKey="Tyden G" first="Gunnar" last="Tyden">Gunnar Tyden</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Department of Transplantation, Karolinksa University</s1><s2>Stockholm</s2><s3>SWE</s3><sZ>6 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Lohmus, Aleksander" sort="Lohmus, Aleksander" uniqKey="Lohmus A" first="Aleksander" last="Lohmus">Aleksander Lohmus</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Nephrology</s1><s2>Tartu</s2><s3>EST</s3><sZ>7 aut.</sZ></inist:fA14><country>Estonie</country><wicri:noRegion>Department of Nephrology</wicri:noRegion></affiliation></author><author><name sortKey="Sommerer, Claudia" sort="Sommerer, Claudia" uniqKey="Sommerer C" first="Claudia" last="Sommerer">Claudia Sommerer</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Department of Nephrology, University of Heidelberg</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Hartmann, Anders" sort="Hartmann, Anders" uniqKey="Hartmann A" first="Anders" last="Hartmann">Anders Hartmann</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Medicine, Rikshospitalet, University of Oslo</s1><s3>NOR</s3><sZ>9 aut.</sZ></inist:fA14><country>Norvège</country><wicri:noRegion>Department of Medicine, Rikshospitalet, University of Oslo</wicri:noRegion></affiliation></author><author><name sortKey="Le Meur, Yann" sort="Le Meur, Yann" uniqKey="Le Meur Y" first="Yann" last="Le Meur">Yann Le Meur</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Nephrology, Central University Hospital Dupuytren</s1><s2>Limoges</s2><s3>FRA</s3><sZ>10 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Limousin</region><settlement type="city">Limoges</settlement></placeName></affiliation></author><author><name sortKey="Oellerich, Michael" sort="Oellerich, Michael" uniqKey="Oellerich M" first="Michael" last="Oellerich">Michael Oellerich</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Department of Clinical Chemistry, Georg-August-Universität Göttingen</s1><s3>DEU</s3><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><settlement type="city">Göttingen</settlement><region type="land" nuts="1">Basse-Saxe</region></placeName><orgName type="university">Université de Göttingen</orgName></affiliation></author><author><name sortKey="Holt, David W" sort="Holt, David W" uniqKey="Holt D" first="David W." last="Holt">David W. Holt</name><affiliation wicri:level="4"><inist:fA14 i1="12"><s1>Analytical Unit, St George's University of London</s1><s2>London</s2><s3>GBR</s3><sZ>12 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region><settlement type="city">Londres</settlement></placeName><orgName type="university">Université de Londres</orgName></affiliation></author><author><name sortKey="Tonshoff, Burkhard" sort="Tonshoff, Burkhard" uniqKey="Tonshoff B" first="Burkhard" last="Tönshoff">Burkhard Tönshoff</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>University Children's Hospital</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>13 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Keown, Paul" sort="Keown, Paul" uniqKey="Keown P" first="Paul" last="Keown">Paul Keown</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>University Hospital Vancouver</s1><s3>CAN</s3><sZ>14 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University Hospital Vancouver</wicri:noRegion></affiliation></author><author><name sortKey="Campbell, Scott" sort="Campbell, Scott" uniqKey="Campbell S" first="Scott" last="Campbell">Scott Campbell</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Department of Nephrology, University of Queensland</s1><s2>Brisbane</s2><s3>AUS</s3><sZ>15 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Brisbane</wicri:noRegion></affiliation></author><author><name sortKey="Mamelok, Richard D" sort="Mamelok, Richard D" uniqKey="Mamelok R" first="Richard D." last="Mamelok">Richard D. Mamelok</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Mamelok Consulting</s1><s2>Palo Alto, CA</s2><s3>USA</s3><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Mamelok Consulting</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">08-0510678</idno><date when="2008">2008</date><idno type="stanalyst">PASCAL 08-0510678 INIST</idno><idno type="RBID">Pascal:08-0510678</idno><idno type="wicri:Area/PascalFrancis/Corpus">003224</idno><idno type="wicri:Area/PascalFrancis/Curation">002E29</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">003347</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">003347</idno><idno type="wicri:doubleKey">0041-1337:2008:Van Gelder T:comparing:mycophenolate:mofetil</idno><idno type="wicri:Area/Main/Merge">009761</idno><idno type="wicri:Area/Main/Curation">008E22</idno><idno type="wicri:Area/Main/Exploration">008E22</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Comparing Mycophenolate Mofetil Regimens for de Novo Renal Transplant Recipients : The Fixed-Dose Concentration-Controlled Trial</title><author><name sortKey="Van Gelder, Teun" sort="Van Gelder, Teun" uniqKey="Van Gelder T" first="Teun" last="Van Gelder">Teun Van Gelder</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Departments of Hospital Pharmacy and Internal Medicine, Erasmus Medical Center</s1><s2>Rotterdam</s2><s3>NLD</s3><sZ>1 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Tedesco Silva, Helio" sort="Tedesco Silva, Helio" uniqKey="Tedesco Silva H" first="Helio" last="Tedesco Silva">Helio Tedesco Silva</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Nephrology, Hospital do Rim e Hipertensao</s1><s2>São Paulo</s2><s3>BRA</s3><sZ>2 aut.</sZ></inist:fA14><country>Brésil</country><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="De Fijter, Johan W" sort="De Fijter, Johan W" uniqKey="De Fijter J" first="Johan W." last="De Fijter">Johan W. De Fijter</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Nephrology, Leiden University Medical Center</s1><s3>NLD</s3><sZ>3 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Department of Nephrology, Leiden University Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Budde, Klemens" sort="Budde, Klemens" uniqKey="Budde K" first="Klemens" last="Budde">Klemens Budde</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Nephrology, Charité University</s1><s2>Berlin</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Kuypers, Dirk" sort="Kuypers, Dirk" uniqKey="Kuypers D" first="Dirk" last="Kuypers">Dirk Kuypers</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Nephrology and Renal Transplantation, Leuven University</s1><s3>BEL</s3><sZ>5 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Department of Nephrology and Renal Transplantation, Leuven University</wicri:noRegion></affiliation></author><author><name sortKey="Tyden, Gunnar" sort="Tyden, Gunnar" uniqKey="Tyden G" first="Gunnar" last="Tyden">Gunnar Tyden</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Department of Transplantation, Karolinksa University</s1><s2>Stockholm</s2><s3>SWE</s3><sZ>6 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Lohmus, Aleksander" sort="Lohmus, Aleksander" uniqKey="Lohmus A" first="Aleksander" last="Lohmus">Aleksander Lohmus</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Nephrology</s1><s2>Tartu</s2><s3>EST</s3><sZ>7 aut.</sZ></inist:fA14><country>Estonie</country><wicri:noRegion>Department of Nephrology</wicri:noRegion></affiliation></author><author><name sortKey="Sommerer, Claudia" sort="Sommerer, Claudia" uniqKey="Sommerer C" first="Claudia" last="Sommerer">Claudia Sommerer</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Department of Nephrology, University of Heidelberg</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Hartmann, Anders" sort="Hartmann, Anders" uniqKey="Hartmann A" first="Anders" last="Hartmann">Anders Hartmann</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Medicine, Rikshospitalet, University of Oslo</s1><s3>NOR</s3><sZ>9 aut.</sZ></inist:fA14><country>Norvège</country><wicri:noRegion>Department of Medicine, Rikshospitalet, University of Oslo</wicri:noRegion></affiliation></author><author><name sortKey="Le Meur, Yann" sort="Le Meur, Yann" uniqKey="Le Meur Y" first="Yann" last="Le Meur">Yann Le Meur</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Nephrology, Central University Hospital Dupuytren</s1><s2>Limoges</s2><s3>FRA</s3><sZ>10 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Limousin</region><settlement type="city">Limoges</settlement></placeName></affiliation></author><author><name sortKey="Oellerich, Michael" sort="Oellerich, Michael" uniqKey="Oellerich M" first="Michael" last="Oellerich">Michael Oellerich</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Department of Clinical Chemistry, Georg-August-Universität Göttingen</s1><s3>DEU</s3><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><settlement type="city">Göttingen</settlement><region type="land" nuts="1">Basse-Saxe</region></placeName><orgName type="university">Université de Göttingen</orgName></affiliation></author><author><name sortKey="Holt, David W" sort="Holt, David W" uniqKey="Holt D" first="David W." last="Holt">David W. Holt</name><affiliation wicri:level="4"><inist:fA14 i1="12"><s1>Analytical Unit, St George's University of London</s1><s2>London</s2><s3>GBR</s3><sZ>12 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region><settlement type="city">Londres</settlement></placeName><orgName type="university">Université de Londres</orgName></affiliation></author><author><name sortKey="Tonshoff, Burkhard" sort="Tonshoff, Burkhard" uniqKey="Tonshoff B" first="Burkhard" last="Tönshoff">Burkhard Tönshoff</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>University Children's Hospital</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>13 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Keown, Paul" sort="Keown, Paul" uniqKey="Keown P" first="Paul" last="Keown">Paul Keown</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>University Hospital Vancouver</s1><s3>CAN</s3><sZ>14 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University Hospital Vancouver</wicri:noRegion></affiliation></author><author><name sortKey="Campbell, Scott" sort="Campbell, Scott" uniqKey="Campbell S" first="Scott" last="Campbell">Scott Campbell</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Department of Nephrology, University of Queensland</s1><s2>Brisbane</s2><s3>AUS</s3><sZ>15 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Brisbane</wicri:noRegion></affiliation></author><author><name sortKey="Mamelok, Richard D" sort="Mamelok, Richard D" uniqKey="Mamelok R" first="Richard D." last="Mamelok">Richard D. Mamelok</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Mamelok Consulting</s1><s2>Palo Alto, CA</s2><s3>USA</s3><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Mamelok Consulting</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Transplantation</title><title level="j" type="abbreviated">Transplantation</title><idno type="ISSN">0041-1337</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Transplantation</title><title level="j" type="abbreviated">Transplantation</title><idno type="ISSN">0041-1337</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antibiotic</term><term>Antiviral</term><term>Clinical trial</term><term>Comparative study</term><term>Concentration</term><term>De novo</term><term>Dose</term><term>Graft</term><term>Homotransplantation</term><term>Immunomodulator</term><term>Immunosuppressive agent</term><term>Kidney</term><term>Mofetil</term><term>Mycophenolate mofetil</term><term>Mycophenolic acid</term><term>Posology</term><term>Therapeutic protocol</term><term>Transplantation</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Mycophénolate mofétil</term><term>Etude comparative</term><term>Immunodépresseur</term><term>Acide mycophénolique</term><term>Traitement</term><term>De novo</term><term>Mofétil</term><term>Transplantation</term><term>Homotransplantation</term><term>Rein</term><term>Dose</term><term>Protocole thérapeutique</term><term>Posologie</term><term>Concentration</term><term>Essai clinique</term><term>Greffe</term><term>Immunomodulateur</term><term>Antiviral</term><term>Antibiotique</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Antibiotique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background. Fixed-dose mycophenolate mofetil (MMF) reduces the incidence of acute rejection after solid organ transplantation. The Fixed-Dose Concentration Controlled trial assessed the feasibility and potential benefit of therapeutic drug monitoring in patients receiving MMF after de novo renal transplant. Methods. Patients were randomized to a concentration-controlled (n=452; target exposure 45 mg hr/L) or a fixed-dose (n=449) MMF-containing regimen. The primary endpoint was treatment failure (a composite ofbiopsy-proven acute rejection [BPAR], graft loss, death, or MMF discontinuation) by 12 months posttransplantation. Results. Mycophenolic acid (MPA) exposures for both groups were similar at most time points and were below 30 mg hr/L in 37.3% of patients at day 3. There was no difference in the incidence of treatment failure (25.6% vs. 25.7%, P=0.81) or BPAR (14.9% vs. 15.5%, P>0.05) between the concentration-controlled and the fixed-dose groups, respectively. We did find a significant relationship between MPA-area under the concentration-time curve on day 3 and the incidence of BPAR in the first month (P=0.009) or in the first year posttransplantation (P=0.006). For later time points (day 10, month 1) there was no significant relationship between area under the concentration-time curve and BPAR (0.2572 and 0.5588, respectively). Conclusions. There was no difference in the incidence of treatment failure between the concentration-controlled and the fixed-dose groups. The applied protocol of MMF dose adjustments based on target MPA exposure was not successful, partly because physicians seemed reluctant to implement substantial dose changes. Current initial MMF doses underexpose more than 35% of patients early after transplantation, increasing the risk for BPAR.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Brésil</li><li>Canada</li><li>Estonie</li><li>France</li><li>Norvège</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>Suède</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Bade-Wurtemberg</li><li>Basse-Saxe</li><li>Berlin</li><li>District de Karlsruhe</li><li>Grand Londres</li><li>Hollande-Méridionale</li><li>Limousin</li><li>Nouvelle-Aquitaine</li><li>Svealand</li><li>État de São Paulo</li></region><settlement><li>Berlin</li><li>Göttingen</li><li>Heidelberg</li><li>Limoges</li><li>Londres</li><li>Rotterdam</li><li>Stockholm</li><li>São Paulo</li></settlement><orgName><li>Université de Göttingen</li><li>Université de Londres</li></orgName></list><tree><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Van Gelder, Teun" sort="Van Gelder, Teun" uniqKey="Van Gelder T" first="Teun" last="Van Gelder">Teun Van Gelder</name></region><name sortKey="De Fijter, Johan W" sort="De Fijter, Johan W" uniqKey="De Fijter J" first="Johan W." last="De Fijter">Johan W. De Fijter</name></country><country name="Brésil"><region name="État de São Paulo"><name sortKey="Tedesco Silva, Helio" sort="Tedesco Silva, Helio" uniqKey="Tedesco Silva H" first="Helio" last="Tedesco Silva">Helio Tedesco Silva</name></region></country><country name="Allemagne"><region name="Berlin"><name sortKey="Budde, Klemens" sort="Budde, Klemens" uniqKey="Budde K" first="Klemens" last="Budde">Klemens Budde</name></region><name sortKey="Oellerich, Michael" sort="Oellerich, Michael" uniqKey="Oellerich M" first="Michael" last="Oellerich">Michael Oellerich</name><name sortKey="Sommerer, Claudia" sort="Sommerer, Claudia" uniqKey="Sommerer C" first="Claudia" last="Sommerer">Claudia Sommerer</name><name sortKey="Tonshoff, Burkhard" sort="Tonshoff, Burkhard" uniqKey="Tonshoff B" first="Burkhard" last="Tönshoff">Burkhard Tönshoff</name></country><country name="Belgique"><noRegion><name sortKey="Kuypers, Dirk" sort="Kuypers, Dirk" uniqKey="Kuypers D" first="Dirk" last="Kuypers">Dirk Kuypers</name></noRegion></country><country name="Suède"><region name="Svealand"><name sortKey="Tyden, Gunnar" sort="Tyden, Gunnar" uniqKey="Tyden G" first="Gunnar" last="Tyden">Gunnar Tyden</name></region></country><country name="Estonie"><noRegion><name sortKey="Lohmus, Aleksander" sort="Lohmus, Aleksander" uniqKey="Lohmus A" first="Aleksander" last="Lohmus">Aleksander Lohmus</name></noRegion></country><country name="Norvège"><noRegion><name sortKey="Hartmann, Anders" sort="Hartmann, Anders" uniqKey="Hartmann A" first="Anders" last="Hartmann">Anders Hartmann</name></noRegion></country><country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Le Meur, Yann" sort="Le Meur, Yann" uniqKey="Le Meur Y" first="Yann" last="Le Meur">Yann Le Meur</name></region></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Holt, David W" sort="Holt, David W" uniqKey="Holt D" first="David W." last="Holt">David W. Holt</name></region></country><country name="Canada"><noRegion><name sortKey="Keown, Paul" sort="Keown, Paul" uniqKey="Keown P" first="Paul" last="Keown">Paul Keown</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Campbell, Scott" sort="Campbell, Scott" uniqKey="Campbell S" first="Scott" last="Campbell">Scott Campbell</name></noRegion></country><country name="États-Unis"><noRegion><name sortKey="Mamelok, Richard D" sort="Mamelok, Richard D" uniqKey="Mamelok R" first="Richard D." last="Mamelok">Richard D. Mamelok</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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